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Completed

NCT Number: NCT04184804

Feasibility Trial on Organic Fruit and Vegetable Consumption in Primary School-children

The aim of this trial is to examine the feasibility of a larger-scale intervention study (regional study in schools run by the Ministry of Education) to increase the consumption of fruits and vegetables in schools towards reducing percentages of childhood obesity prevalence rates by at least 0.5% every two years for all children, using an organic-based healthy eating intervention package for primary school children and their parents.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary schools

Limassol, Cyprus

About this study

Pre-implementation phase: All necessary approvals (Bioethics, Ministry of Education) for the implementation of the study will be taken. Initial contacts with school directors will be done to obtain their approval.

Preparatory phase: Contact with the parents' union will be done, to explain the aim of the study and bring them in contact with interested organic companies in order to reach an agreement for the cost of providing organic fruits and vegetables in school lunch menus. Following the agreement, parents and children will be informed about the study through separate seminars for children and parents and a flyer that will be sent at home. Signed consent forms will be obtained. Teachers will also be taken on board and information pertaining to the overall scope and objectives of the study will be shared with them. This phase will also involve pre-testing of all the data collection tools. After pre-testing, necessary modifications will be carried out in the tools.

Intervention phase: At the beginning of the intervention (March 2020), a baseline questionnaire with demographic data and a food frequency questionnaire (FFQ) to record the children's diet habits will be administered to parents. Organic fruits and vegetables will be introduced at the school lunch menu and one workshop for children will be implemented per month. The workshops will include interactive games for children. Signs will be posted in various school areas. At the end of the intervention (end of May 2020), a seminar for parents will take place in order to discuss their children's impression of the program. FFQ and evaluation questionnaires (feedback on the intervention) will be administered to parents.

For the control group: No intervention (usual education). School directors are contacted and their approval is requested to conduct the study that aims to assess the eating habits of primary school children. The parents will be informed about the study with a flyer that will be sent at home through school and signed informed consents will be obtained. A baseline questionnaire with demographic data and an ffq will be administered to parents about their children in March 2020. Another ffq will be administered at the end of May 2020.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary school children attending the all-day school meals

Exclusion criteria

  • No exclusion criteria are applied

Treatment and study plan

behavioral intervention

Behavioral

The intervention package will be consisted of:

  • Introduction of organic fruits and vegetables (by replacing the conventional ones) in school lunch menus
  • Signs in school areas about organic fruits and vegetables
  • Workshops and interactive games for children
  • Seminars for parents

Primary outcomes

  1. Change in reported consumption frequency of fruit and vegetables (organic and conventional) in children

    Time frame: baseline, 9 weeks

    Self-reported consumption of foods based on a food frequency questionnaire. This is based on the consumption frequency of food items for the last three months.

Secondary outcomes

  1. Accrual rates

    Time frame: 9 weeks

    Number of participants recruited

  2. Accrual losses

    Time frame: 9 weeks

    Number of participants declined/withdrawn to participate

  3. Acceptability of the intervention by children (qualitative, proportions)

    Time frame: 9 weeks

    Use of an evaluation questionnaire on intervention acceptability, which will be administered to parents at the end of the intervention. This includes 4 closed and 4 open-ended questions.

  4. Change in number of servings of fruits and vegetables consumed

    Time frame: 9 weeks

    Each teacher in charge during lunch period records the number of fruits and salad servings consumed (photos of non-consumed fruits and salad - 1 per week).

  5. Change in reported consumption frequency of other food groups (meat and sweets/fats/oils groups) in children

    Time frame: baseline, 9 weeks

    Self-reported consumption of foods based on a food frequency questionnaire. This is based on the consumption frequency of food items for the last three months.

Sponsors and collaborators

Lead sponsor

Cyprus University of Technology

Other

Registry information

Official study title

A School-based Intervention Programme to Promote Organic Fruit and Vegetable Consumption in Primary School-children: A Cluster-randomized Feasibility Trial (PRISHEC)

Acronym: PRISHEC

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 4, 2019
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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